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Trial record 2 of 7 for:
"Gynecomastia"
Open Label Arimidex in Gynecomastia
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00241436
First received: October 17, 2005
Last updated: January 25, 2011
Last verified: January 2011
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Purpose
The purpose of this study is to evaluate the safety, effectiveness, pharmacokinetics and pharmacodynamics of anastrozole (ARIMIDEX™) in the treatment of boys with gynecomastia.
| Condition | Intervention | Phase |
|---|---|---|
| Gynecomastia | Drug: Anastrozole (ARIMIDEX™) | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-Label Pharmacokinetic and Pharmacodynamic Study of Anastrozole (Arimidex™) Used to Treat Pubertal Boys With Gynecomastia of Recent Onset |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- Assess anastrazole PK in boys aged 11-18 yrs. in pubertal boys with gynecomastia of less than 12 months duration
Secondary Outcome Measures:
- Determine efficacy by the response rate following 6 months of treatment
| Estimated Enrollment: | 35 |
| Study Start Date: | June 2005 |
| Study Completion Date: | November 2006 |
| Primary Completion Date: | November 2006 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 11 Years to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Signed informed consent/assent (as per local requirements), males aged 11-18 yrs. (after his 10th and prior to 19th birthday), gynecomastia, one breast measuring ≥ 2 cm in diameter (by ultrasound or caliper measurement) that has not decreased during the prior 3 month period by medical history and has been present for 12 months or less (date of onset based on best estimate of treating physician after discussion with patient and or patient's parent/guardian), normal renal liver and thyroid function, no evidence of hormone producing tumor, no evidence of hypogonadism or androgen resistance.
Exclusion Criteria:
- Patients who have been given medications known to cause gynecomastia within the previous 6 months, involvement in the planning and conduct of the study (includes AZ staff and investigative site staff), previous enrollment in the present study, investigators opinion patient would be unable to comply with study protocol.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00241436
Please refer to this study by its ClinicalTrials.gov identifier: NCT00241436
Locations
| United States, Florida | |
| Research Site | |
| Jacksonville, Florida, United States | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | AstraZeneca Arimidex Medical Sciences Director, MD | AstraZeneca |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00241436 History of Changes |
| Other Study ID Numbers: |
D5394C00001 |
| Study First Received: | October 17, 2005 |
| Last Updated: | January 25, 2011 |
Additional relevant MeSH terms:
|
Gynecomastia Breast Diseases Skin Diseases Anastrozole Antineoplastic Agents, Hormonal Antineoplastic Agents Aromatase Inhibitors |
Steroid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Estrogen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on July 14, 2017